PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Report

• Report Number: 1020279-2025-01732
• Event Type: Injury
• Date Received: October 20, 2025
• Report Date: April 30, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: MBH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01732, PREVIOUSLY SUBMITTED ON 20-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE .CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: CASE (B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE.CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01732.

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 3 (01-JUL-2025 TO 30-SEP-2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: LEGION POROUS CR COCR FEMORAL COMPONENTS: IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND EIGHTY-SIX (5,386) KNEES BETWEEN 17-FEB-2010 AND 27-FEB-2025. OF THESE, A TWO HUNDRED THIRTY-FIVE (235) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: FIFTY-EIGHT (58) KNEES DUE TO INFECTION, THIRTY-FIVE (35) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, NINETEEN (19) DUE TO PAIN, ELEVEN (11) DUE TO PATELLOFEMORAL PAIN, FORTY-FOUR (44) DUE TO PATELLA EROSION, FOURTEEN (14) DUE TO ARTHROFIBROSIS, TWELVE (12) DUE TO FRACTURE, EIGHT (8) DUE TO MALALIGNMENT, THREE (3) DUE TO LYSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, THREE (3) DUE TO METAL RELATED PATHOLOGY, TWO (2) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE FEMORAL, TWO (2) DUE TO OTHER-UNKNOWN REASONS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, THESE REASONS FOR REVISION CANNOT BE DEFINITIVELY LINKED TO THE INDIVIDUAL FEMORAL COMPONENTS REFERENCED IN THE .CSV FILE AND REPORTED AS INVOLVED IN REVISION SURGERIES. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE LEGION TOTAL KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR REPORTS THAT FOR THE LEGION CR POROUS WITH COCR FEMORAL COMPONENT SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. AGE AND GENDER ADJUSTED HAZARD MODELLING (HR=1.26 (1.11, 1.43), P<0.001) FURTHER SHOWS THAT THIS DIFFERENCE IS SIGNIFICANT. IN THESE KNEES, THE FREQUENCY OF PATELLA EROSION (44, 0.8%) WAS HIGHER THAN IN ALL OTHER KNEES (2,661, 0.3%). THIS WAS ASSOCIATED WITH APPROXIMATELY HALF OF THE PROCEDURES (2018, 41%) WITH LEGION CR COCR POROUS NOT RESURFACING THE PATELLA AT THE TIME OF THE TKA, WHICH MAY ACCOUNT FOR HIGHER RATE OF REVISION. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287403-1-L1,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 3 LEFT,71423243,,71423243,,00885556030707,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L2,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 3 LEFT,71423243,,71423243,,00885556030707,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L3,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 3 LEFT,71423243,,71423243,,00885556030707,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L4,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 4 LEFT,71423244,,71423244,,00885556030936,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L5,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 6 LEFT,71423246,,71423246,,00885556032343,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L6,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 7 LEFT,71423247,,71423247,,00885556032633,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L7,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 7 LEFT,71423247,,71423247,,00885556032633,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L8,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 4 RIGHT,71423254,,71423254,,00885556031674,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L9,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 4 RIGHT,71423254,,71423254,,00885556031674,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L10,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 6 RIGHT,71423256,,71423256,,00885556030394,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L11,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 6 RIGHT,71423256,,71423256,,00885556030394,K073325,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L12,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 LEFT,71425203,,71425203,,00885556108598,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L13,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 LEFT,71425203,,71425203,,00885556108598,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L14,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 LEFT,71425203,,71425203,,00885556108598,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L15,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 LEFT,71425203,,71425203,,00885556108598,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L16,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 LEFT,71425203,,71425203,,00885556108598,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L17,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L18,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L19,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L20,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L21,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L22,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L23,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L24,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L25,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L26,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L27,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L28,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L29,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L30,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L31,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L32,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L33,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L34,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L35,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L36,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L37,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L38,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L39,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L40,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L41,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 LEFT,71425204,,71425204,,00885556108581,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L42,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L43,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L44,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L45,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L46,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L47,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L48,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L49,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L50,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L51,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L52,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L53,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L54,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L55,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L56,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L57,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L58,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L59,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L60,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L61,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L62,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L63,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L64,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L65,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 LEFT,71425205,,71425205,,00885556108574,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L66,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L67,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L68,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L69,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L70,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L71,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L72,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L73,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L74,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L75,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L76,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L77,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L78,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L79,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L80,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L81,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L82,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L83,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L84,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L85,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L86,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 LEFT,71425206,,71425206,,00885556108567,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L87,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L88,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L89,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L90,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L91,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L92,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L93,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L94,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L95,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L96,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L97,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L98,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L99,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L100,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L101,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L102,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L103,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L104,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L105,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L106,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L107,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L108,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L109,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L110,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L111,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L112,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 LEFT,71425207,,71425207,,00885556108550,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L113,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L114,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L115,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L116,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L117,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L118,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L119,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L120,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L121,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L122,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 LEFT,71425208,,71425208,,00885556108543,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L123,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 2 RIGHT,71425212,,71425212,,00885556108536,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L124,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 2 RIGHT,71425212,,71425212,,00885556108536,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L125,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 RIGHT,71425213,,71425213,,00885556108529,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L126,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 RIGHT,71425213,,71425213,,00885556108529,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L127,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 RIGHT,71425213,,71425213,,00885556108529,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L128,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 RIGHT,71425213,,71425213,,00885556108529,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L129,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 3 RIGHT,71425213,,71425213,,00885556108529,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L130,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L131,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L132,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L133,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L134,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L135,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L136,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L137,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L138,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L139,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L140,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L141,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L142,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L143,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L144,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L145,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 4 RIGHT,71425214,,71425214,,00885556108512,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L146,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L147,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L148,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L149,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L150,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L151,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L152,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L153,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L154,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L155,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L156,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L157,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L158,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L159,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L160,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L161,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L162,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L163,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L164,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L165,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L166,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L167,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 5 RIGHT,71425215,,71425215,,00885556108505,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L168,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L169,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L170,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L171,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L172,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L173,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L174,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L175,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L176,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L177,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L178,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L179,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L180,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L181,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L182,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L183,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L184,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L185,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L186,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L187,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L188,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L189,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L190,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L191,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L192,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L193,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L194,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L195,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L196,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L197,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L198,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L199,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L200,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 6 RIGHT,71425216,,71425216,,00885556108499,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L201,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L202,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L203,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L204,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L205,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L206,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L207,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L208,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L209,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L210,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L211,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L212,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L213,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L214,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L215,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L216,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L217,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L218,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L219,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L220,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L221,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L222,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L223,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L224,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L225,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L226,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L227,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L228,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L229,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L230,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 7 RIGHT,71425217,,71425217,,00885556108482,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L231,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 RIGHT,71425218,,71425218,,00885556108475,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L232,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 RIGHT,71425218,,71425218,,00885556108475,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L233,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 RIGHT,71425218,,71425218,,00885556108475,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L234,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 RIGHT,71425218,,71425218,,00885556108475,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287403-1-L235,,10/20/2025,6/3/2025,LEGION Total Knee System,LEGION POROUS CRUCIATE RETAINING HYRDROXYAPATITE FEMORAL SIZE 8 RIGHT,71425218,,71425218,,00885556108475,K091543,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted, one (1) knee required revision due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION POROUS CR CoCr Femoral Component was implanted. Of these, a two hundred thirty-five (235) knees required revision due to the following reasons: fifty-eight (58) knees due to infection, thirty-five (35) due to loosening, seventeen (17) due to instability, nineteen (19) due to pain, eleven (11) due to patellofemoral pain, forty-four (44) due to patella erosion, fourteen (14) due to arthrofibrosis, twelve (12) due to fracture, eight (8) due to malalignment, three (3) due to lysis, one (1) due to wear tibial insert, three (3) due to metal related pathology, two (2) due to patella maltracking, one (1) due to bearing dislocation, one (1) due to implant breakage patella, two (2) due to synovitis, two (2) due to implant breakage femoral, two (2) due to other reasons. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual femoral components referenced in the .csv file and reported as involved in revision surgeries.;;Timeframe of Registry Data: Implantations conducted between 17-Feb-2010 and 27-Feb-2025 in Australia;;Analysis Conducted: Based on the most recent safety and performance evaluation, the LEGION POROUS CR CoCr Femoral Component presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total five thousand three-hundred and eighty-six (5386) knees underwent primary TKA in which a LEGION Porous CR CoCr Femoral Component was implanted in Australia between 17-Feb-2010 and 27-Feb-2025. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 1.3% (1.0%-1.6%) vs 1.0% (1.0%-1.0%) of the class;-At 2nd post-operative year: 2.3% (2.0%-2.8%) vs 1.9% (1.8%-1.9%) of the class;-At 3rd post-operative year: 3.3% (2.8%-3.8%) vs 2.4% (2.4%-2.5%) of the class;-At 4th post-operative year: 3.7% (3.2%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 4.2% (3.7%-4.9%) vs 3.2% (3.2%-3.3%) of the class;-At 6th post-operative year: 4.7% (4.1%-5.4%) vs 3.5% (3.5%-3.6%) of the class;-At 7th post-operative year: 4.9% (4.3%-5.6%) vs 3.8% (3.8%-3.9%) of the class;-At 8th post-operative year: 5.6% (4.8%-6.4%) vs 4.1% (4.1%-4.2%) of the class;-At 9th post-operative year: 5.9% (5.1%-6.8%) vs 4.4% (4.4%-4.5%) of the class;-At 10th post-operative year: 6.4% (5.5%-7.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 7.5% (6.3%-8.9%) vs 5.1% (5.0%-5.1%) of the class;-At 12th post-operative year: 8.2% (6.8%-10.0%) vs 5.4% (5.3%-5.5%) of the class;-At 13th post-operative year: 8.2% (6.8%-10.0%) vs 5.7% (5.7%-5.8%) of the class;-At 14th post-operative year: 8.2% (6.8%-10.0%) vs 6.1% (6.0%-6.2%) of the class;;Based on non-overlapping 95% confidence intervals, the LEGION CR Porous CoCr Femoral Component showed higher cumulative revision rate than the class average. Age and gender adjusted hazard modelling (HR=1.26 (1.11, 1.43), p<0.001) further shows that this difference is significant. In these knees, frequency of patella erosion (44, 0.8%) was higher than in all other knees (2,661, 0.3%). This was associated with approximately half of the procedures (2018, 41%) with LEGION CR CoCr Porous not resurfacing the patella at the time of the TKA, which may account for higher rate of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-1,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 2RT,71422024,,71422024,,03596010496201,K032683,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-2,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ5 LEFT,71928328,,71928328,,00885556154700,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-3,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ6 LEFT,71928329,,71928329,,00885556154694,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-4,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ8 LEFT,71928331,,71928331,,00885556154670,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-5,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ5 RIGHT,71928335,,71928335,,00885556154632,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-6,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ4 RIGHT,71928334,,71928334,,00885556154649,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-7,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ4 RIGHT,71928334,,71928334,,00885556154649,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-8,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ6 RIGHT,71928336,,71928336,,00885556154625,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-9,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ6 RIGHT,71928336,,71928336,,00885556154625,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-10,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ7 RIGHT,71928337,,71928337,,00885556154618,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-11,,4/30/2026,3/16/2026,GENESIS II TKA System,GENII HA CTD C/R FEM SZ7 RIGHT,71928337,,71928337,,00885556154618,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-12,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 RIGHT,71422026,,71422026,,03596010496218,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-13,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 RIGHT,71422026,,71422026,,03596010496218,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-14,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 RIGHT,71422026,,71422026,,03596010496218,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-15,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 LEFT,71422042,,71422042,,03596010496287,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-16,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 LEFT,71422042,,71422042,,03596010496287,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-17,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 LEFT,71422042,,71422042,,03596010496287,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-18,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 LEFT,71422042,,71422042,,03596010496287,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-19,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 3 LEFT,71422042,,71422042,,03596010496287,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-20,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-21,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-22,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-23,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-24,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-25,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-26,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-27,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-28,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-29,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-30,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-31,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-32,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-33,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-34,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-35,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-36,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 LEFT,71422052,,71422052,,03596010496331,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-37,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-38,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-39,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-40,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-41,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-42,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-43,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-44,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-45,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-46,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-47,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-48,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-49,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-50,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-51,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-52,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-53,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-54,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-55,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-56,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-57,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-58,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-59,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-60,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-61,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-62,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-63,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-64,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-65,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-66,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-67,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-68,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-69,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-70,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-71,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-72,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-73,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-74,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-75,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-76,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-77,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-78,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-79,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-80,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-81,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-82,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-83,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-84,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-85,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-86,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-87,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-88,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-89,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-90,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-91,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-92,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 8 RIGHT,71422036,,71422036,,03596010496263,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-93,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-94,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-95,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-96,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-97,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-98,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-99,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-100,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-101,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-102,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-103,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-104,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-105,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-106,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-107,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-108,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-109,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-110,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-111,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-112,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-113,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-114,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-115,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-116,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-117,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-118,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-119,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-120,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-121,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-122,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-123,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-124,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-125,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-126,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-127,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-128,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-129,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-130,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-131,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-132,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-133,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-134,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-135,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-136,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-137,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-138,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-139,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-140,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-141,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-142,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-143,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-144,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-145,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-146,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-147,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-148,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-149,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-150,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-151,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-152,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-153,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-154,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-155,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-156,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-157,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-158,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-159,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-160,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-161,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-162,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-163,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-164,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-165,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-166,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-167,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-168,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-169,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-170,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-171,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-172,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-173,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-174,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-175,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-176,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-177,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-178,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-179,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-180,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-181,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-182,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-183,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-184,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-185,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-186,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-187,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-188,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-189,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-190,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-191,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-192,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-193,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-194,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-195,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-196,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-197,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-198,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-199,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-200,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-201,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-202,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-203,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-204,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-205,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-206,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-207,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-208,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-209,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-210,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-211,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-212,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-213,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-214,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-215,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-216,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-217,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-218,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-219,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-220,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-221,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-222,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-223,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-224,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-225,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-226,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-227,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-228,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-229,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-230,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-231,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-232,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-233,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-234,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-235,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-236,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-237,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-238,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-239,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-240,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-241,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-242,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-243,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-244,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-245,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-246,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-247,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-248,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-249,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-250,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-251,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-252,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-253,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-254,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-255,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-256,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-257,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-258,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-259,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-260,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-261,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-262,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-263,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-264,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-265,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-266,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-267,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-268,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-269,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-270,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-271,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-272,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-273,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-274,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-275,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-276,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-277,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-278,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-279,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-280,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-281,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-282,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-283,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-284,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-285,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-286,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-287,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-288,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-289,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-290,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-291,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-292,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-293,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-294,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-295,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-296,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-297,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-298,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-299,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-300,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-301,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-302,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-303,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-304,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-305,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-306,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-307,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-308,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-309,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-310,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-311,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-312,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-313,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-314,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-315,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-316,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-317,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-318,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-319,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-320,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-321,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-322,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-323,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-324,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-325,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-326,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-327,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-328,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-329,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-330,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-331,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-332,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-333,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-334,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-335,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-336,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-337,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-338,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-339,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 7 LEFT,71422050,,71422050,,03596010496324,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-340,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-341,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-342,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-343,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-344,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-345,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-346,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-347,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-348,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-349,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-350,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-351,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-352,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-353,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-354,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-355,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-356,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-357,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-358,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-359,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-360,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-361,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-362,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-363,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-364,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-365,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-366,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-367,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-368,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-369,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-370,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-371,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-372,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-373,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-374,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-375,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-376,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-377,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-378,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-379,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-380,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-381,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-382,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-383,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-384,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-385,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-386,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-387,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-388,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-389,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-390,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-391,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-392,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-393,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-394,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-395,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-396,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-397,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-398,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-399,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-400,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-401,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-402,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-403,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-404,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-405,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-406,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-407,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-408,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-409,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-410,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-411,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-412,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-413,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-414,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-415,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-416,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-417,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-418,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-419,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-420,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-421,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-422,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-423,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-424,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-425,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-426,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-427,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-428,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-429,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-430,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-431,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-432,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-433,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-434,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-435,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-436,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-437,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-438,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-439,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-440,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-441,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-442,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-443,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-444,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-445,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-446,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-447,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-448,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-449,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-450,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-451,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-452,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-453,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-454,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-455,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-456,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-457,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-458,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-459,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-460,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-461,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-462,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-463,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-464,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-465,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-466,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-467,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-468,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-469,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-470,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-471,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-472,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-473,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-474,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-475,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-476,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-477,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-478,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-479,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-480,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-481,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-482,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-483,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-484,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319298-1-485,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II HA Porous CR Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the five hundred seventy-two (572) revision surgeries reported for these implants, four hundred eighty-five (485) revisions were associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all five hundred seventy-two (572) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: one hundred fourteen (114) knees due to infection, one hundred eighteen (118) knees due to loosening, thirty-four (34) knees due to instability, fifty (50) knees due to pain, seventy (70) knees due to patellofemoral pain, eighty-one (81) knees due to patella erosion, twenty-six (26) knees due to fracture, twenty-three (23) knees due to arthrofibrosis, six (6) knees due to wear tibial insert, five (5) knees due to lysis, fourteen (14) knees due to malalignment, two (2) knees due to implant breakage tibial insert, five (5) knees due to metal related pathology, three (3) knees due to incorrect sizing, five (5) knees due to patella maltracking, one (1) knee due to bearing dislocation, one (1) knee due to prosthesis dislocation, two (2) knees due to synovitis, one (1) knee due to implant breakage tibial, four (4) knees due to wear patella, three (3) knees due to implant breakage femoral, one (1) knee due to tumour, and three (3) knees due to other reasons.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all five hundred seventy-two (572) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 485 revisions associated with knees that had previously received a GENESIS II Porous CR HA Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 485 cases.;Timeframe of Registry Data: Implantations conducted between 14-Oct-1999 and 11-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eight thousand nine hundred forty-five (8,945) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous CR or HA Porous CR variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.0% (0.8%¿1.2%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.4% (2.1%¿2.8%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 3.2% (2.9%¿3.6%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 3.8% (3.4%¿4.2%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 4.3% (3.9%¿4.8%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 4.8% (4.4%¿5.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.0% (4.6%¿5.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 5.4% (4.9%¿5.9%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 5.7% (5.2%¿6.2%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.0% (5.5%¿6.5%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 6.3% (5.8%¿6.9%) vs 5.0% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 6.6% (6.0%¿7.2%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 6.9% (6.3%¿7.5%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 7.0% (6.4%¿7.6%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 7.3% (6.7%¿8.0%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 7.9% (7.3%¿8.7%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 8.2% (7.5%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 8.4% (7.7%¿9.2%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 8.7% (7.9%¿9.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 8.9% (8.1%¿9.8%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 9.3% (8.3%¿10.4%) vs 8.5% (8.3%¿8.6%) of the class.;- At 22nd postoperative year: 9.3% (8.3%¿10.4%) vs 8.8% (8.6%¿8.9%) of the class.;- At 23rd postoperative year: 9.3% (8.3%¿10.4%) vs 9.0% (8.8%¿9.2%) of the class.;- At 24th postoperative year: 9.3% (8.3%¿10.4%) vs 9.3% (9.1%¿9.5%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II CR Hybrid and the class overlap at the 1 and 19-24 year post-operative time points, indicating no statistically significant difference in long-term revision rates. At the 2-18 year post-operative time points, the cumulative revision rates for GENESIS II CR Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II CR Hybrid were patellar complications (n= 160), component loosening (n= 118), and infection (n= 114). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Among revised cases, 44.6% involved removal of the patella only or insert/patella, which was higher than observed for the class (27.6%). However, no statistically significant difference in overall revision rates was identified based on patellar resurfacing usage.;Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II CR Hybrid femoral or tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision, based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II CR Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319397-1-1,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 3 RIGHT,71931636,,71931636,,00885556055632,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II HA Porous PS Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the seventy-one (71) revision surgeries reported for these implants, five (5) revisions were associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all seventy-one (71) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: nine (9) knees due to infection, seventeen (17) knees due to loosening, three (3) knees due to instability, six (6) knees due to pain, six (6) knees due to patella erosion, eighteen (18) knees due to patellofemoral pain, two (2) knees due to fracture, three (3) knees due to arthrofibrosis, two (2) knees due to wear tibial insert, one (1) knee due to lysis, one (1) knee due to incorrect sizing, one (1) knee due to bearing dislocation, and two (2) knees due to osteonecrosis.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all seventy-one (71) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 revisions associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 5 cases.;Timeframe of Registry Data: Implantations conducted between 10-Apr-2000 and 8-Mar-2017 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred twenty-eight (728) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.7% (0.9%¿2.9%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 3.6% (2.5%¿5.2%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 4.4% (3.2%¿6.2%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 5.0% (3.6%¿6.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 5.6% (4.1%¿7.5%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 6.6% (5.0%¿8.7%) vs 3.5% (3.5%¿3.5%) of the class.;- At 7th postoperative year: 6.8% (5.1%¿8.9%) vs 3.8% (3.8%¿3.8%) of the class.;- At 8th postoperative year: 8.0% (6.2%¿10.3%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 8.5% (6.6%¿10.8%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 8.5% (6.6%¿10.8%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 8.5% (6.6%¿10.8%) vs 5.0% (4.9%¿5.1%) of the class.;- At 12th postoperative year: 9.3% (7.3%¿11.7%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 9.7% (7.7%¿12.2%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 9.7% (7.7%¿12.2%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 10.2% (8.1%¿12.8%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 10.7% (8.5%¿13.5%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 10.7% (8.5%¿13.5%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 10.7% (8.5%¿13.5%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 11.6% (9.1%¿14.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.6% (9.1%¿14.6%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 11.6% (9.1%¿14.6%) vs 8.5% (8.3%¿8.6%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II PS Hybrid and the class overlap at the 1 year post-operative time point, indicating no statistically significant difference. At the 2-21 year post-operative time points, the cumulative revision rates for GENESIS II PS Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II PS Hybrid were patellar complications (n=24), loosening (n=17) and infection (n=9). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. Additionally, patella complications involve the patella and not the GENESIS II femoral or tibial components. Resurfacing the patella at the time of TKA remains a surgeon¿s decision based on each patient¿s conditions, although not addressing the patella (e.g. resurfacing) at the time of TKA is considered a major contributing factor to anterior knee pain, reoperation, and revisions. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Overall, the present analysis of GENESIS II PS Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319397-1-2,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 7 RIGHT,71931640,,71931640,,00885556055526,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II HA Porous PS Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the seventy-one (71) revision surgeries reported for these implants, five (5) revisions were associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all seventy-one (71) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: nine (9) knees due to infection, seventeen (17) knees due to loosening, three (3) knees due to instability, six (6) knees due to pain, six (6) knees due to patella erosion, eighteen (18) knees due to patellofemoral pain, two (2) knees due to fracture, three (3) knees due to arthrofibrosis, two (2) knees due to wear tibial insert, one (1) knee due to lysis, one (1) knee due to incorrect sizing, one (1) knee due to bearing dislocation, and two (2) knees due to osteonecrosis.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all seventy-one (71) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 revisions associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 5 cases.;Timeframe of Registry Data: Implantations conducted between 10-Apr-2000 and 8-Mar-2017 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred twenty-eight (728) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.7% (0.9%¿2.9%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 3.6% (2.5%¿5.2%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 4.4% (3.2%¿6.2%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 5.0% (3.6%¿6.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 5.6% (4.1%¿7.5%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 6.6% (5.0%¿8.7%) vs 3.5% (3.5%¿3.5%) of the class.;- At 7th postoperative year: 6.8% (5.1%¿8.9%) vs 3.8% (3.8%¿3.8%) of the class.;- At 8th postoperative year: 8.0% (6.2%¿10.3%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 8.5% (6.6%¿10.8%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 8.5% (6.6%¿10.8%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 8.5% (6.6%¿10.8%) vs 5.0% (4.9%¿5.1%) of the class.;- At 12th postoperative year: 9.3% (7.3%¿11.7%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 9.7% (7.7%¿12.2%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 9.7% (7.7%¿12.2%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 10.2% (8.1%¿12.8%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 10.7% (8.5%¿13.5%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 10.7% (8.5%¿13.5%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 10.7% (8.5%¿13.5%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 11.6% (9.1%¿14.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.6% (9.1%¿14.6%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 11.6% (9.1%¿14.6%) vs 8.5% (8.3%¿8.6%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II PS Hybrid and the class overlap at the 1 year post-operative time point, indicating no statistically significant difference. At the 2-21 year post-operative time points, the cumulative revision rates for GENESIS II PS Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II PS Hybrid were patellar complications (n=24), loosening (n=17) and infection (n=9). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. Additionally, patella complications involve the patella and not the GENESIS II femoral or tibial components. Resurfacing the patella at the time of TKA remains a surgeon¿s decision based on each patient¿s conditions, although not addressing the patella (e.g. resurfacing) at the time of TKA is considered a major contributing factor to anterior knee pain, reoperation, and revisions. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Overall, the present analysis of GENESIS II PS Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319397-1-3,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 5 LEFT,71931644,,71931644,,00885556056769,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II HA Porous PS Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the seventy-one (71) revision surgeries reported for these implants, five (5) revisions were associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all seventy-one (71) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: nine (9) knees due to infection, seventeen (17) knees due to loosening, three (3) knees due to instability, six (6) knees due to pain, six (6) knees due to patella erosion, eighteen (18) knees due to patellofemoral pain, two (2) knees due to fracture, three (3) knees due to arthrofibrosis, two (2) knees due to wear tibial insert, one (1) knee due to lysis, one (1) knee due to incorrect sizing, one (1) knee due to bearing dislocation, and two (2) knees due to osteonecrosis.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all seventy-one (71) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 revisions associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 5 cases.;Timeframe of Registry Data: Implantations conducted between 10-Apr-2000 and 8-Mar-2017 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred twenty-eight (728) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.7% (0.9%¿2.9%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 3.6% (2.5%¿5.2%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 4.4% (3.2%¿6.2%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 5.0% (3.6%¿6.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 5.6% (4.1%¿7.5%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 6.6% (5.0%¿8.7%) vs 3.5% (3.5%¿3.5%) of the class.;- At 7th postoperative year: 6.8% (5.1%¿8.9%) vs 3.8% (3.8%¿3.8%) of the class.;- At 8th postoperative year: 8.0% (6.2%¿10.3%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 8.5% (6.6%¿10.8%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 8.5% (6.6%¿10.8%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 8.5% (6.6%¿10.8%) vs 5.0% (4.9%¿5.1%) of the class.;- At 12th postoperative year: 9.3% (7.3%¿11.7%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 9.7% (7.7%¿12.2%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 9.7% (7.7%¿12.2%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 10.2% (8.1%¿12.8%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 10.7% (8.5%¿13.5%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 10.7% (8.5%¿13.5%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 10.7% (8.5%¿13.5%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 11.6% (9.1%¿14.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.6% (9.1%¿14.6%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 11.6% (9.1%¿14.6%) vs 8.5% (8.3%¿8.6%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II PS Hybrid and the class overlap at the 1 year post-operative time point, indicating no statistically significant difference. At the 2-21 year post-operative time points, the cumulative revision rates for GENESIS II PS Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II PS Hybrid were patellar complications (n=24), loosening (n=17) and infection (n=9). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. Additionally, patella complications involve the patella and not the GENESIS II femoral or tibial components. Resurfacing the patella at the time of TKA remains a surgeon¿s decision based on each patient¿s conditions, although not addressing the patella (e.g. resurfacing) at the time of TKA is considered a major contributing factor to anterior knee pain, reoperation, and revisions. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Overall, the present analysis of GENESIS II PS Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319397-1-4,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 5 RIGHT,71931638,,71931638,,00885556056356,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II HA Porous PS Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the seventy-one (71) revision surgeries reported for these implants, five (5) revisions were associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all seventy-one (71) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: nine (9) knees due to infection, seventeen (17) knees due to loosening, three (3) knees due to instability, six (6) knees due to pain, six (6) knees due to patella erosion, eighteen (18) knees due to patellofemoral pain, two (2) knees due to fracture, three (3) knees due to arthrofibrosis, two (2) knees due to wear tibial insert, one (1) knee due to lysis, one (1) knee due to incorrect sizing, one (1) knee due to bearing dislocation, and two (2) knees due to osteonecrosis.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all seventy-one (71) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 revisions associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 5 cases.;Timeframe of Registry Data: Implantations conducted between 10-Apr-2000 and 8-Mar-2017 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred twenty-eight (728) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.7% (0.9%¿2.9%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 3.6% (2.5%¿5.2%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 4.4% (3.2%¿6.2%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 5.0% (3.6%¿6.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 5.6% (4.1%¿7.5%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 6.6% (5.0%¿8.7%) vs 3.5% (3.5%¿3.5%) of the class.;- At 7th postoperative year: 6.8% (5.1%¿8.9%) vs 3.8% (3.8%¿3.8%) of the class.;- At 8th postoperative year: 8.0% (6.2%¿10.3%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 8.5% (6.6%¿10.8%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 8.5% (6.6%¿10.8%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 8.5% (6.6%¿10.8%) vs 5.0% (4.9%¿5.1%) of the class.;- At 12th postoperative year: 9.3% (7.3%¿11.7%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 9.7% (7.7%¿12.2%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 9.7% (7.7%¿12.2%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 10.2% (8.1%¿12.8%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 10.7% (8.5%¿13.5%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 10.7% (8.5%¿13.5%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 10.7% (8.5%¿13.5%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 11.6% (9.1%¿14.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.6% (9.1%¿14.6%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 11.6% (9.1%¿14.6%) vs 8.5% (8.3%¿8.6%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II PS Hybrid and the class overlap at the 1 year post-operative time point, indicating no statistically significant difference. At the 2-21 year post-operative time points, the cumulative revision rates for GENESIS II PS Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II PS Hybrid were patellar complications (n=24), loosening (n=17) and infection (n=9). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. Additionally, patella complications involve the patella and not the GENESIS II femoral or tibial components. Resurfacing the patella at the time of TKA remains a surgeon¿s decision based on each patient¿s conditions, although not addressing the patella (e.g. resurfacing) at the time of TKA is considered a major contributing factor to anterior knee pain, reoperation, and revisions. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Overall, the present analysis of GENESIS II PS Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319397-1-5,,4/30/2026,3/16/2026,GENESIS II TKA System,GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 5 RIGHT,71931638,,71931638,,00885556056356,K030612,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II HA Porous PS Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seven hundred twenty-eight (728) knees underwent primary TKA between 10-Apr-2000 and 8-Mar-2017, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. This total includes constructs approved for use in the United States under FDA product codes JWH and MBH. Of the seventy-one (71) revision surgeries reported for these implants, five (5) revisions were associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH.;The AOANJRR report provides the complete list of reasons for revision for all seventy-one (71) revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBH. The reported reasons for revision include: nine (9) knees due to infection, seventeen (17) knees due to loosening, three (3) knees due to instability, six (6) knees due to pain, six (6) knees due to patella erosion, eighteen (18) knees due to patellofemoral pain, two (2) knees due to fracture, three (3) knees due to arthrofibrosis, two (2) knees due to wear tibial insert, one (1) knee due to lysis, one (1) knee due to incorrect sizing, one (1) knee due to bearing dislocation, and two (2) knees due to osteonecrosis.;In consideration of the above, the analysis conducted in the AOANJRR registry report encompasses all seventy-one (71) revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 revisions associated with knees that had previously received a GENESIS II HA Porous PS Femoral Component approved under FDA product code MBH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 5 cases.;Timeframe of Registry Data: Implantations conducted between 10-Apr-2000 and 8-Mar-2017 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred twenty-eight (728) knees underwent primary TKA in Australia between 14-Oct-1999 and 11-Nov-2025, using GENESIS II Femoral Component (Porous PS or HA Porous PS variants) with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st postoperative year: 1.7% (0.9%¿2.9%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 3.6% (2.5%¿5.2%) vs 1.8% (1.8%¿1.9%) of the class.;- At 3rd postoperative year: 4.4% (3.2%¿6.2%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 5.0% (3.6%¿6.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th postoperative year: 5.6% (4.1%¿7.5%) vs 3.2% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 6.6% (5.0%¿8.7%) vs 3.5% (3.5%¿3.5%) of the class.;- At 7th postoperative year: 6.8% (5.1%¿8.9%) vs 3.8% (3.8%¿3.8%) of the class.;- At 8th postoperative year: 8.0% (6.2%¿10.3%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 8.5% (6.6%¿10.8%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 8.5% (6.6%¿10.8%) vs 4.7% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 8.5% (6.6%¿10.8%) vs 5.0% (4.9%¿5.1%) of the class.;- At 12th postoperative year: 9.3% (7.3%¿11.7%) vs 5.3% (5.3%¿5.4%) of the class.;- At 13th postoperative year: 9.7% (7.7%¿12.2%) vs 5.7% (5.6%¿5.7%) of the class.;- At 14th postoperative year: 9.7% (7.7%¿12.2%) vs 6.0% (5.9%¿6.1%) of the class.;- At 15th postoperative year: 10.2% (8.1%¿12.8%) vs 6.4% (6.3%¿6.4%) of the class.;- At 16th postoperative year: 10.7% (8.5%¿13.5%) vs 6.8% (6.7%¿6.9%) of the class.;- At 17th postoperative year: 10.7% (8.5%¿13.5%) vs 7.2% (7.1%¿7.3%) of the class.;- At 18th postoperative year: 10.7% (8.5%¿13.5%) vs 7.5% (7.4%¿7.6%) of the class.;- At 19th postoperative year: 11.6% (9.1%¿14.6%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.6% (9.1%¿14.6%) vs 8.2% (8.0%¿8.3%) of the class.;- At 21st postoperative year: 11.6% (9.1%¿14.6%) vs 8.5% (8.3%¿8.6%) of the class.;The confidence intervals for the cumulative percent revision rates of GENESIS II PS Hybrid and the class overlap at the 1 year post-operative time point, indicating no statistically significant difference. At the 2-21 year post-operative time points, the cumulative revision rates for GENESIS II PS Hybrid were statistically significantly higher than the class, as determined by non-overlapping 95% confidence intervals.;The most frequently reported reasons for revision for GENESIS II PS Hybrid were patellar complications (n=24), loosening (n=17) and infection (n=9). Infection is recognized as a complication influenced by patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device. Additionally, patella complications involve the patella and not the GENESIS II femoral or tibial components. Resurfacing the patella at the time of TKA remains a surgeon¿s decision based on each patient¿s conditions, although not addressing the patella (e.g. resurfacing) at the time of TKA is considered a major contributing factor to anterior knee pain, reoperation, and revisions. All reported post-operative complications were consistent with the potential harms identified in the DFMEAs for the GENESIS II Total Knee System.;Overall, the present analysis of GENESIS II PS Hybrid using AOANJRR data is consistent with findings from the previous clinical evaluation and does not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: LEGION POROUS CR COCR FEMORAL COMPONENTS: IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND EIGHTY-SIX (5,386) KNEES BETWEEN 17-FEB-2010 AND 27-FEB-2025. OF THESE, A TWO HUNDRED THIRTY-FIVE (235) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: FIFTY-EIGHT (58) KNEES DUE TO INFECTION, THIRTY-FIVE (35) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, NINETEEN (19) DUE TO PAIN, ELEVEN (11) DUE TO PATELLOFEMORAL PAIN, FORTY-FOUR (44) DUE TO PATELLA EROSION, FOURTEEN (14) DUE TO ARTHROFIBROSIS, TWELVE (12) DUE TO FRACTURE, EIGHT (8) DUE TO MALALIGNMENT, THREE (3) DUE TO LYSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, THREE (3) DUE TO METAL RELATED PATHOLOGY, TWO (2) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE FEMORAL, TWO (2) DUE TO OTHER-UNKNOWN REASONS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, THESE REASONS FOR REVISION CANNOT BE DEFINITIVELY LINKED TO THE INDIVIDUAL FEMORAL COMPONENTS REFERENCED IN THE .CSV FILE AND REPORTED AS INVOLVED IN REVISION SURGERIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65043		PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO	MBH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR	Unknown

Terms

Patient problem · 14

• Arthralgia
• Arthrofibrosis
• Aseptic loosening
• Deformity/ Disfigurement
• Erosion
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Metal Related Pathology
• Osteolysis
• Pain
• Periprosthetic fracture
• Synovitis
• Unspecified Infection

Product problems · 5

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Malposition of Device
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission