PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Description of Event or Problem

BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY HIP REPLACEMENT PROCEDURES: 1. PRIMARY PROCEDURES: - TANDEM UNIPOLAR OXINIUM HEAD COMPONENTS: IMPLANTED IN TWENTY-THREE (23) HIPS BETWEEN 10-JUL-2006 AND 25-SEP-2007. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO FRACTURE, AND ONE (1) HIP DUE TO CHONDROLYSIS/ACETABULAR EROSION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE.

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY HIP REPLACEMENT PROCEDURES: 1. PRIMARY PROCEDURES: - TANDEM UNIPOLAR OXINIUM HEAD COMPONENTS: IMPLANTED IN TWENTY-THREE (23) HIPS BETWEEN 10-JUL-2006 AND 25-SEP-2007. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO FRACTURE, AND ONE (1) HIP DUE TO CHONDROLYSIS/ACETABULAR EROSION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE TANDEM BIPOLAR/UNIPOLAR HIP SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF TWENTY-THREE (23) PROCEDURES WITH TANDEM UNIPOLAR OXINIUM HEAD COMPONENTS HAVE BEEN PERFORMED IN AUSTRALIA BETWEEN 10-JUL-2006 AND 25-SEP-2007. FOR THE ENTIRE EXAMINED PERIOD OF 1 TO 5 YEARS, THE TANDEM UNIPOLAR OXINIUM IS OBSERVED TO HAVE HIGHER MEAN REVISION RATES COMPARED TO THE CLASS AVERAGE OF OTHER UNIPOLAR HIPS. HOWEVER, BASED ON OVERLAPPING CONFIDENCE INTERVALS, THIS DIFFERENCE IS NOT STATISTICALLY SIGNIFICANT FROM 2 YEARS ONWARD. IT IS IMPORTANT TO NOTE THAT THE TWO RECORDED FAILURES OCCURRED WITHIN THE FIRST YEAR AND THAT THE SAMPLE SIZE IS ONLY 23 PATIENTS. THEREFORE, A KAPLAN-MEIER SURVIVORSHIP IS NOT STATISTICALLY HIGHLY RELIABLE. ACCORDINGLY, CONFIDENCE INTERVALS FOR THE SUBJECT DEVICE ARE VERY WIDE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00325803-1-L1,,7/6/2026,5/7/2026,TANDEM Bipolar/Unipolar Hip System,OXINIUM UNIPOLAR HEAD 51MM OUTER DIAMETER,71321051,,71321051,,03596010534736,K934353,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty three (23) hips underwent primary hip procedures between 10-Jul-2006 and 25-Sep-2007, using a TANDEM Unipolar Oxinium Head component. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual head reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty three (23) hips underwent primary hip procedures between 10-Jul-2006 and 25-Sep-2007, using a TANDEM Unipolar Oxinium Head components. From these, two (2) hips were later revised due to the following reasons: one (1) hip due to fracture, and one (1) hip due to chondrolysis/acetabular erosion. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 10-Jul-2006 and 25-Sep-2007 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the TANDEM Bipolar/Unipolar Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of twenty three (23) procedures with TANDEM Unipolar Oxinium Head components have been performed in Australia between 10-Jul-2006 and 25-Sep-2007. ;For the entire examined period of 1 to 5 years, the TANDEM Unipolar Oxinium is observed to have higher mean revision rates compared to the class average of other Unipolar hips. However, based on overlapping confidence intervals, this difference is not statistically significant from 2 years onward. It is important to note that the two recorded failures occurred within the first year and that the sample size is only 23 patients. Therefore, a Kaplan-Meier survivorship is not statistically highly reliable. Accordingly, confidence intervals for the subject device are very wide.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.3%-31.2%) vs 2.1% (2.0%-2.2%) of the class.;-At 2nd postoperative year: 8.9% (2.3%-31.2%) vs 2.8% (2.6%-2.9%) of the class.;-At 3rd postoperative year: 8.9% (2.3%-31.2%) vs 3.3% (3.2%-3.5%) of the class.;-At 4th postoperative year: 8.9% (2.3%-31.2%) vs 3.9% (3.7%-4.1%) of the class.;-At 5th postoperative year: 8.9% (2.3%-31.2%) vs 4.5% (4.3%-4.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325803-1-L2,,7/6/2026,5/7/2026,TANDEM Bipolar/Unipolar Hip System,OXINIUM UNIPOLAR HEAD 53MM OUTER DIAMETER,71321053,,71321053,,03596010534750,K934353,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty three (23) hips underwent primary hip procedures between 10-Jul-2006 and 25-Sep-2007, using a TANDEM Unipolar Oxinium Head component. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual head reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty three (23) hips underwent primary hip procedures between 10-Jul-2006 and 25-Sep-2007, using a TANDEM Unipolar Oxinium Head components. From these, two (2) hips were later revised due to the following reasons: one (1) hip due to fracture, and one (1) hip due to chondrolysis/acetabular erosion. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 10-Jul-2006 and 25-Sep-2007 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the TANDEM Bipolar/Unipolar Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of twenty three (23) procedures with TANDEM Unipolar Oxinium Head components have been performed in Australia between 10-Jul-2006 and 25-Sep-2007. ;For the entire examined period of 1 to 5 years, the TANDEM Unipolar Oxinium is observed to have higher mean revision rates compared to the class average of other Unipolar hips. However, based on overlapping confidence intervals, this difference is not statistically significant from 2 years onward. It is important to note that the two recorded failures occurred within the first year and that the sample size is only 23 patients. Therefore, a Kaplan-Meier survivorship is not statistically highly reliable. Accordingly, confidence intervals for the subject device are very wide.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.3%-31.2%) vs 2.1% (2.0%-2.2%) of the class.;-At 2nd postoperative year: 8.9% (2.3%-31.2%) vs 2.8% (2.6%-2.9%) of the class.;-At 3rd postoperative year: 8.9% (2.3%-31.2%) vs 3.3% (3.2%-3.5%) of the class.;-At 4th postoperative year: 8.9% (2.3%-31.2%) vs 3.9% (3.7%-4.1%) of the class.;-At 5th postoperative year: 8.9% (2.3%-31.2%) vs 4.5% (4.3%-4.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;