GENESIS UNI KNEE FEMORAL COMPONENT COCR

Report

• Report Number: 1020279-2025-00939
• Event Type: Injury
• Date Received: May 23, 2025
• Report Date: October 16, 2025
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: HSX
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: GM
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025) SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, IN THE ENDOPROTHESENREGISTER JOINT REGISTRY (EPRD) FROM GERMANY, A TOTAL OF FIFTY-TWO (52) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN 01-AUG-2013 AND 30-NOV-2017, USING GENESIS UNI FEMORAL COMPONENT COCR. FROM THESE, TWELVE (12) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) KNEE DUE TO INFECTION, EIGHT (8) KNEES DUE TO ASEPTIC LOOSENING AND THREE (3) KNEES DUE TO OTHER-UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 01-AUG-2013 AND 30-NOV-2017 IN GERMANY. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE GENESIS UNI FEMORAL COMPONENT COCR PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT OF THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND RISK REDUCTION MEASURES INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF FIFTY-TWO (52) PRIMARY UKA PROCEDURES WITH GENESIS UNI FEMORAL COMPONENT COCR HAVE BEEN PERFORMED IN GERMANY BETWEEN 01-AUG-2013 AND 30-NOV-2017. AT 2-3 YEARS AND 8 YEARS, THE CUMULATIVE REVISION RATES FOR GENESIS UNI FEMORAL COMPONENT COCR ARE STATISTICALLY SIGNIFICANTLY HIGHER THAN THE CLASS BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS. AT 1 YEAR AND 4-7 YEARS, THE CUMULATIVE REVISION RATES FOR GENESIS UNI FEMORAL COMPONENT COCR ARE NOT STATISTICALLY SIGNIFICANTLY DIFFERENT THAN THE CLASS BASED ON OVERLAPPING CONFIDENCE INTERVALS. THESE DIFFERENCES MAY BE PARTIALLY ACCOUNTED FOR BY THE VERY LOW VOLUME OF IMPLANTATIONS, LEADING TO LARGE CONFIDENCE INTERVALS. THE FOLLOWING CUMULATIVE REVISION RATES WITH 95% CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: AT 1ST POSTOPERATIVE YEAR: 3.8% (0.0%-8.9%) VS 2.9% (2.7%-3.0%) OF THE CLASS. AT 2ND POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 4.6% (4.5%-4.8%) OF THE CLASS. AT 3RD POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 5.7% (5.5%-5.9%) OF THE CLASS. AT 4TH POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 6.6% (6.4%-6.8%) OF THE CLASS. AT 5TH POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 7.2% (7.0%-7.5%) OF THE CLASS. AT 6TH POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 8.0% (7.7%-8.2%) OF THE CLASS.O AT 7TH POSTOPERATIVE YEAR: 17.5% (6.4%-27.2%) VS 8.6% (8.3%-8.9%) OF THE CLASS. AT 8TH POSTOPERATIVE YEAR: 22.6% (9.7%-33.7%) VS 9.3% (9.0%-9.7%) 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.

Additional Manufacturer Narrative · 0

CORRECTED DATA: A2 (MEAN AGE HAS BEEN CORRECTED FROM 60 YEARS TO 61), B5 (EVENT NARRATIVE), D1 (¿GENESIS UNI KNEE FEMORAL COMPONENT COCR¿ REMOVED FROM BRAND NAME, AS THE 3500A FORM INCORPORATES SEVERAL PRODUCTS), H2 (TOTAL QUANTITY OF SUMMARIZED EVENTS IS NOW 19), H6 (ADDITIONAL CODES ADDED FOR ¿HEALTH EFFECT - CLINICAL CODE¿ AND ¿MEDICAL DEVICE PROBLEM CODE¿ PERTAINING TO THE ADDITIONAL EVENTS INCORPORATED TO THIS 3500A FORM SUBMISSION). H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER (B)(4), COMMUNICATED ON JULY 1, 2025. AS A RESULT, THE MDR WITH REFERENCE 1020279-2025-00939 INCORPORATES ALL THE REAL WORD DATA SHARING THE FOLLOWING BUNDLING CRITERIA: REGISTRATION NUMBER: 1020279, DATA SOURCE: GERMAN ENDOPROSTHESIS REGISTER (EPRD), REPORT TYPE: SERIOUS INJURY, PRODUCT CLASSIFICATION CODE: HSX. ADDITIONAL COMPLAINTS HAVE BEEN ADDED SINCE THE PREVIOUS SUBMISSION ON 23-MAY-2025: CASE-(B)(4). EXCEPT FOR THE CORRECTED FIELDS NOTED ABOVE UNDER ¿CORRECTED DATA¿, THE INFORMATION PROVIDED IN THE REQUIRED FIELDS OF THE PRIOR 3500A FORM SUBMITTED ON 23-MAY-2025 REMAINS UNCHANGED. REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE GERMAN ENDOPROSTHESIS REGISTER (EPRD) SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY UKAS. GENESIS UNI COCR FEMORAL COMPONENT: - A TOTAL OF FIFTY-TWO (52) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN (B)(6) 2013 AND (B)(6) 2017, USING GENESIS UNI FEMORAL COMPONENT COCR. FROM THESE, TWELVE (12) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) KNEE DUE TO INFECTION, EIGHT (8) KNEES DUE TO ASEPTIC LOOSENING AND THREE (3) KNEES DUE TO OTHER UNKNOWN REASONS. JOURNEY II UK OXINIUM FEMORAL COMPONENT: - A TOTAL OF TWO HUNDRED SEVENTY-EIGHT (278) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN (B)(6) 2020 AND (B)(6) 2024, USING JOURNEY II UK FEMORAL COMPONENT OXINIUM. FROM THESE, SEVEN (7) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO FRACTURE, THREE (3) KNEES DUE TO ASEPTIC LOOSENING, (3) KNEES DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF NINETEEN (19) REVISIONS HAS BEEN REPORTED IN THE GERMAN ENDOPROSTHESIS REGISTER (EPRD) FOR PRIMARY UKAS. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, BOTH THE GENESIS UNI KNEE SYSTEM AND THE JOURNEY II UK PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT OF THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND RISK REDUCTION MEASURES INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. GERMAN ENDOPROSTHESENREGISTER (EPRD) DETAIL REPORTS FOR THE CITED SMITH+NEPHEW PROSTHESES USED IN PRIMARY UKAS WERE REVIEWED. A TOTAL OF FIFTY-TWO (52) PRIMARY UKA PROCEDURES WITH GENESIS UNI COCR FEMORAL COMPONENTS HAVE BEEN PERFORMED IN GERMANY BETWEEN (B)(6) 2013 AND (B)(6) 2017. AT 2¿3 YEARS AND 8 YEARS POST-IMPLANTATION, THE CUMULATIVE REVISION RATES FOR THE GENESIS UNI COCR FEMORAL COMPONENTS ARE STATISTICALLY SIGNIFICANTLY HIGHER THAN THOSE OBSERVED FOR THE CLASS, AS INDICATED BY NON-OVERLAPPING CONFIDENCE INTERVALS. AT 1 YEAR AND 4¿7 YEARS, THE CUMULATIVE REVISION RATES FOR THE GENESIS UNI COCR FEMORAL COMPONENTS DO NOT DIFFER STATISTICALLY FROM THE CLASS, BASED ON OVERLAPPING CONFIDENCE INTERVALS. THESE VARIATIONS MAY BE PARTIALLY ATTRIBUTABLE TO THE LOW IMPLANTATION VOLUME, WHICH RESULTS IN WIDE CONFIDENCE INTERVALS. A TOTAL OF TWO HUNDRED SEVENTY-EIGHT (278) PRIMARY UKA PROCEDURES WITH JOURNEY II UK OXINIUM FEMORAL COMPONENT HAVE BEEN PERFORMED IN GERMANY BETWEEN (B)(6) 2020 AND (B)(6) 2024. AT 3 YEARS, THE CUMULATIVE REVISION RATE FOR THE JOURNEY II UK OXINIUM FEMORAL COMPONENT DOES NOT DEMONSTRATE A STATISTICALLY SIGNIFICANT DIFFERENCE FROM THE UKA CLASS, AS INDICATED BY OVERLAPPING CONFIDENCE INTERVALS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED. CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00267234-1-L1,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L2,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L3,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L4,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L5,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L6,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L7,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L8,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L9,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L10,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L11,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00267234-1-L12,,5/23/2025,5/5/2025,GENESIS UNI CoCr femoral component,GENESIS UNI CoCr femoral component,,,,,,K912735,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of fifty-two (52) knees underwent primary UKA procedures between 01-Aug-2013 and 30-Nov-2017, using GENESIS UNI femoral component CoCr. From these, twelve (12) knees were later revised due to the following complications: one (1) knee due to infection, eight (8) knees due to aseptic loosening and three (3) knees due to other-unknown reasons. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Aug-2013 and 30-Nov-2017 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS UNI femoral component CoCr presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty-two (52) primary UKA procedures with GENESIS UNI femoral component CoCr have been performed in Germany between 01-Aug-2013 and 30-Nov-2017. At 2-3 years and 8 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are statistically significantly higher than the class based on non-overlapping confidence intervals. At 1 year and 4-7 years, the cumulative revision rates for GENESIS UNI femoral component CoCr are not statistically significantly different than the class based on overlapping confidence intervals. These differences may be partially accounted for by the very low volume of implantations, leading to large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 3.8% (0.0%-8.9%) vs 2.9% (2.7%-3.0%) of the class.;o At 2nd postoperative year: 17.5% (6.4%-27.2%) vs 4.6% (4.5%-4.8%) of the class.;o At 3rd postoperative year: 17.5% (6.4%-27.2%) vs 5.7% (5.5%-5.9%) of the class.;o At 4th postoperative year: 17.5% (6.4%-27.2%) vs 6.6% (6.4%-6.8%) of the class.;o At 5th postoperative year: 17.5% (6.4%-27.2%) vs 7.2% (7.0%-7.5%) of the class.;o At 6th postoperative year: 17.5% (6.4%-27.2%) vs 8.0% (7.7%-8.2%) of the class.;o At 7th postoperative year: 17.5% (6.4%-27.2%) vs 8.6% (8.3%-8.9%) of the class.;o At 8th postoperative year: 22.6% (9.7%-33.7%) vs 9.3% (9.0%-9.7%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279828-1-L1,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L2,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L3,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L4,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L5,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L6,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279828-1-L7,,10/16/2025,6/4/2025,JOURNEY II UK femoral component Oxinium,JOURNEY II UK femoral component Oxinium,,,,,,K190085,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, one (1) patient requiered revision surgery due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred seventy-eight (278) knees underwent primary UKA procedures between 01-Aug-2020 and 31-Mar-2024, using JOURNEY II UK femoral component Oxinium. From these, seven (7) knees were later revised due to the following reasons: one (1) knee due to fracture, three (3) knees due to aseptic loosening, (3) knees due to other-unknown reasons. No further information is available;;Timeframe of Registry data: Implantations conducted between 01-Aug-2020 and 31-Mar-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II UK femoral component Oxinium presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of two hundred seventy-eight (278) primary UKA procedures with JOURNEY II UK femoral component Oxinium have been performed in Germany between 01-Aug-2020 and 31-Mar-2024. At 3 years, the cumulative revision rates for JOURNEY II UK femoral component Oxinium are not statistically significantly different from the UKA class based on overlapping confident intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.6% (0.0%¿3.2%) vs 2.9% (2.7%¿3.0%) of the class.;o At 2nd postoperative year: 5.1% (0.0%¿10.0%) vs 4.7% (4.5%¿4.8%) of the class.;o At 3rd postoperative year: 9.8% (0.0%¿19.5%) vs 5.7% (5.5%¿5.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

IT WAS REPORTED THAT, IN THE ENDOPROTHESENREGISTER JOINT REGISTRY (EPRD) FROM GERMANY, A TOTAL OF FIFTY-TWO (52) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN 01-AUG-2013 AND 30-NOV-2017, USING GENESIS UNI FEMORAL COMPONENT COCR. FROM THESE, TWELVE (12) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) KNEE DUE TO INFECTION, EIGHT (8) KNEES DUE TO ASEPTIC LOOSENING AND THREE (3) KNEES DUE TO OTHER-UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 01-AUG-2013 AND 30-NOV-2017 IN GERMANY.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE GERMAN ENDOPROSTHESIS REGISTER (EPRD) SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY UKAS. GENESIS UNI COCR FEMORAL COMPONENT: - A TOTAL OF FIFTY-TWO (52) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN (B)(6) 2013 AND (B)(6) 2017, USING GENESIS UNI FEMORAL COMPONENT COCR. FROM THESE, TWELVE (12) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) KNEE DUE TO INFECTION, EIGHT (8) KNEES DUE TO ASEPTIC LOOSENING AND THREE (3) KNEES DUE TO OTHER UNKNOWN REASONS. JOURNEY II UK OXINIUM FEMORAL COMPONENT: - A TOTAL OF TWO HUNDRED SEVENTY-EIGHT (278) KNEES UNDERWENT PRIMARY UKA PROCEDURES BETWEEN (B)(6) 2020 AND (B)(6) 2024, USING JOURNEY II UK FEMORAL COMPONENT OXINIUM. FROM THESE, SEVEN (7) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO FRACTURE, THREE (3) KNEES DUE TO ASEPTIC LOOSENING, (3) KNEES DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF NINETEEN (19) REVISIONS HAS BEEN REPORTED IN THE GERMAN ENDOPROSTHESIS REGISTER (EPRD) FOR PRIMARY UKAS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1071085	GENESIS UNI KNEE FEMORAL COMPONENT COCR	PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER	HSX	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR	Unknown	Required Intervention| H

Terms

Patient problem · 4

• Aseptic loosening
• Insufficient Information
• Periprosthetic fracture
• Unspecified Infection

Product problems · 2

• Adverse Event Without Identified Device or Use Problem
• Loosening of Implant Not Related to Bone-Ingrowth

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission